Independent Statistical Center Function

Consistent with the latest FDA and EMA draft guidances on adaptive design, drug development sponsors are increasing their use of external independent Data Monitoring Committees (DMC’s) for their adaptive designed Late Phase clinical  trials. To carry out their mission, DMC’s require timely and accurate statistical analyses and summaries of accumulating clinical trial data.     

Independent Statistical Centers (ISC’s) provide these analyses to DMC’s.

Cytel has highly knowledgeable clinical trial statisticians, statistical programmers, and database managers with extensive ISC performance experience.